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PERIOCHIP 2.5 MG DENTAL INSERT

Active substance(s): CHLORHEXIDINE GLUCONATE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Periochip 2.5 mg Dental Insert

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dental insert contains chlorhexidine digluconate 2.5 mg.
Excipient(s):
For a full list of excipients, see Section 6.1.

3

PHARMACEUTICAL FORM
Dental insert.
Bullet shaped, orange brown dental insert.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Periochip with scaling and root planing is indicated as an adjunctive
antimicrobial treatment for moderate to severe chronic periodontal disease in
adults with pocketing. Periochip may be used as part of a periodontal
treatment programme.

4.2

Posology and method of administration
Dosage
Adults including the elderly: Following mechanical debridement, a Periochip
is placed in each of the periodontal pockets to be treated. Retreatment with
Periochip following mechanical plaque removal at 3 month intervals may
provide additional benefit if pocket depth remains ≥5mm.
The Periochip biodegrades in the periodontal pocket over about a 7-day period
and no return visit to the dental clinic to remove the dental insert is necessary.
The patient should be instructed to continue normal oral hygiene procedures.
No restrictions on dietary habits are needed.
Children and adolescents: Periochip is not indicated in children, since safety
and efficacy in this age group have not been established.
Method of administration
Isolate and dry the periodontal pocket. Open an aluminium blister cavity
containing one Periochip. Pick up the dental insert with a pair of forceps so
that the rounded end points away from the forceps. Rapidly insert the dental
insert into the pocket to its maximum depth and release. The dental insert can
be further manoeuvred into position using the tips of the forceps or a flat

plastic instrument. Periochip insertion into periodontal pockets is rapid. The
dental insert's consistency allows placement into the pocket with little
discomfort to the patient.

4.3

Contraindications
Hypersensitivity to chlorhexidine digluconate or to any of the excipients listed
in section 6.1.

4.4

Special warnings and precautions for use
There have been individual reports of systemic hypersensitivity following
placement of Periochip. Local hypersensitivity reactions such as gingival
swelling are common.
Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have
been reported in patients receiving products containing chlorhexidine. These
usually occur from within minutes to a few hours of dosing. Patients should
therefore be instructed to seek immediate medical attention if they develop
allergic symptoms such as skin rash, itch, generalised swelling, breathing
difficulties, light headedness, rapid heart rate, upset stomach or diarrhoea after
exposure to chlorhexidine.

4.5

Interaction with other medicinal products and other forms of interaction
Chlorhexidine is known to be incompatible with anionic agents which may be
present in some toothpastes and with sucrose in the diet. Such interactions do
not impact significantly on the efficacy of Periochip. Treatment remained
effective with Periochip during clinical studies in which patients continued
with regular tooth brushing and their normal diet.
Nystatin is known to be antagonistic to the efficacy of chlorhexidine.
Concomitant use of medications containing this active ingredient should be
avoided.

4.6

Fertility, pregnancy and lactation
Pregnancy
In reproduction and fertility studies with chlorhexidine digluconate, no
evidence of impaired fertility was observed in rats at doses up to
100mg/kg/day, and no evidence of harm to the foetus was observed in rats and
rabbits at doses up to 300mg/kg/day and 40mg/kg/day, respectively.
Since controlled studies in pregnant women have not been conducted, the
expected benefits of the drug to the mother should be weighed against possible
risks to the foetus.
Lactation
Animal studies using rats have shown no evidence of toxic effects to suckling
pups when chlorhexidine was administered to dams. The chlorhexidine doses
used were greater than 100 times the amount administered to a person treated
with twelve Periochips. It is not documented whether or not chlorhexidine is

excreted in human milk, therefore caution should be exercised when
administering the drug to nursing women.
4.7

Effects on ability to drive and use machines
Not relevant.

4.8

Undesirable effects
Approximately one third of patients experience adverse reactions, usually
transient, during the first few days after chip insertion. These may also be due
to the mechanical placement of the dental insert in the periodontal pocket or as
a result of the preceding scaling procedure. The most commonly reported are
gastrointestinal system disorders: dental, gingival or oral soft tissue reactions
or are otherwise described as application site reactions.
Adverse reactions have been ranked under headings of frequency using the
following convention: very common (≥1/10); common (≥1/100 to <1/10);
uncommon (≥1/1,000 to <1/100); frequency not known (cannot be estimated
from the available data):
Infections and infestations:
Uncommon:
Upper respiratory tract infection
Blood and lymphatic system disorders:
Uncommon:
Lymphadenopathy
Immune disorders:
Frequency not known:

Hypersensitivity including anaphylactic shock (see
sections 4.3 and 4.4)

Nervous system disorders:
Uncommon:
Dizziness, neuralgia
Gastrointestinal disorders:
Very common:
Toothache
Common:
Gingival swelling, gingival pain, gingival bleeding
Uncommon:
Gingival hyperplasia, gingival recession, gingival
pruritus, mouth ulceration, sensitivity of teeth
Skin disorders:
Frequency not known:

Allergic skin reactions such as dermatitis, pruritus,
erythema, eczema, rash, urticaria, skin irritation, and
blisters

General disorders and administration site conditions:
Uncommon:
Malaise, influenza like illness, pyrexia
The following adverse reactions have been derived from post-marketing
reports on Periochip: systemic hypersensitivity, anaphylactoid reaction, soft
tissue necrosis, cellulitis and abscess related to the application site, loss of
taste and gingival discoloration.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance

of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

4.9

Overdose
No case of overdose has been reported.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Stomatological preparations; Antiinfectives
and antiseptics for local oral treatment.
ATC code: A01AB03.
General properties
Chlorhexidine digluconate is an antimicrobial agent active against a wide
spectrum of Gram-positive and Gram-negative organisms, yeast, fungi,
facultative anaerobes and aerobes. Chlorhexidine is predominately a
“membrane-active” agent; it damages the outer membrane in the bacteria.
In an ex vivo study of plaque samples, taken from 25 patients with periodontal
disease, exposure to escalating doses of chlorhexidine, resulted in elimination
of 99% of subgingival bacteria at concentrations of 125µg/mL or more. The
MIC values for various oral cavity micro-organisms to chlorhexidine are
tabulated below:
Micro-organisms

MIC (µg/mL)

Porphyromonas gingivalis

62

Prevotella intermedia

62

Campylobacter concisus

31

Capnocytophaga ochracea

250

Hemophilus aphrophilus

8

Streptococcus mutans

8

Actinobacillus actinomycetemcomitans

62

Bacteroides forsythus

125

Bacteroides melaninogenious

62

Eikenella corrodens

62

Streptococcus intermedia

125

Streptococcus sanguis

125

Veilonella parvule

62

Bacteroides fragilis

250

Capnocytophaga sp.

500

Other information
Clinical microbiology studies with chlorhexidine mouthrinse have
demonstrated the efficacy of chlorhexidine in reducing the numbers of
periodontopathic bacteria, with a minimal risk of developing resistance. These
studies, demonstrating the use of chlorhexidine for 6 months and up to 2 years,
did not result in overgrowth of pathogenic bacteria or changes in the
antimicrobial susceptibility of the oral flora.
Chlorhexidine resistance to bacteria usually results from either changes in the
bacterial cell membrane, limiting chlorhexidine uptake, or low-level plasmidencoded resistance. However, since neither of these mechanisms have been
associated with the Bacteroides sp., major pathogens in periodontal pockets,
and since the concentrations of chlorhexidine delivered by the Periochip are
relatively high, there is no concern about the development of chlorhexidine
resistance following Periochip administration.
Periochip
In a 6-month study of the Periochip, microbiological examination by DNA
probe of bacteria from periodontal pockets, showed a sharp decrease in microorganisms.

5.2

Pharmacokinetic properties
In order to maintain a therapeutically effective concentration, Periochip
delivers a sustained release of chlorhexidine from the gelatin matrix of the
dental insert over a period of seven days. This release is most rapid within the
first 24 hours after dental insert placement with a peak concentration of about
2000µg/mL at 2 hours, followed by a slow reduction in the concentration of
chlorhexidine over a period of seven days. A microbiologically effective dose
of at least 125µg/mL is maintained during the release period.
There was no evidence of any systemic absorption following dental insert
insertion. In addition, low systemic absorption of chlorhexidine has been
demonstrated in studies conducted in animals and humans employing high oral
doses of chlorhexidine.

5.3

Preclinical safety data
Periochip has been tested for cytotoxicity in vitro, for mutagenicity using the
mouse micronucleus assay, for oral mucosal irritation potential using a
Hamster cheek pouch model and for subchronic oral toxicity in a 30 day
ingestion study in rats.
Cytotoxicity
In Chinese Hamster lung cells (V79), Periochip showed marked in vitro
cytotoxicity. The cytotoxicity of the Periochip was considerably less than that
of chlorhexidine digluconate alone and was reduced by the addition of a rat
liver-derived, metabolic activation system. Thus, the cytotoxicity of the active,
chlorhexidine digluconate, is reduced when incorporated into the Periochip

Mutagenicity
The potential of Periochip to induce chromosomal or other damage was
assessed in vivo by evaluating the formation of micronuclei in immature bone
marrow erythrocytes in mice. No significant chromosomal or other damage
was observed with the Periochip for any test dose up to and including
1240mg/kg chlorhexidine digluconate compared to the vehicle control.
Oral mucosal irritation
The potential of Periochip to induce irritation was evaluated through surgical
insertion into Hamster cheek pouches for either 7 or 14 days. Mucosal
irritation was observed after removal of the Periochips and, through
comparison with sites treated with placebo dental inserts, was considered to be
caused by the chlorhexidine digluconate. There were few instances of
significant differences in erythema and oedema. The effects were transitory
and the animals had recovered seven days after dental insert removal,
indicating either that the initial localised effects were biologically insignificant
or that the healing process was rapid.
Oral toxicity
Daily dosing for 30 days with up to 37.5mg/kg of Periochip powder
containing chlorhexidine digluconate caused no adverse effect in rats.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Hydrolysed gelatin (cross-linked with glutaraldehyde)
Glycerol
Purified water

6.2

Incompatibilities
Nystatin is known to be antagonistic to the efficacy of chlorhexidine.

6.3

Shelf life
30 months.

6.4

Special precautions for storage
Do not store above 30ºC.

6.5

Nature and contents of container
Blister (laminated aluminium foil blister packs), each containing 2, 10 and 20
dental inserts.

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Dexcel-Pharma Limited
7 Sopwith Way, Drayton Fields
Daventry
Northamptonshire
NN11 8PB
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 14017/0035

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15/11/1996 / 14/11/2006

10

DATE OF REVISION OF THE TEXT
19/11/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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